BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 3

    MDR report key: 4001078 · Received July 17, 2014

    Report

    Report Number
    2023446-2014-00091
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPRESS 3 CENTRIFUGE UNIT WAS REPORTED TO BE OPENING WITH LID OPEN DURING A CYCLE. THERE WERE NO INJURIES AND NO PT SAMPLES WERE LOST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT LID OPENS DURING SPINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420533 EXPRESS 3 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1